Trial Outcomes & Findings for Analysis of BPD in Premature Infants With Typical Imaging Changes (NCT NCT04163822)

NCT ID: NCT04163822

Last Updated: 2023-04-04

Results Overview

the number of death/total number（%）

• Recruitment status: COMPLETED
• Target enrollment: 256 participants
• Primary outcome timeframe: between 28 days after birth and 2 years of age
• Results posted on: 2023-04-04

Participant Flow

Participant milestones

Measure	Typical Imaging Findings (+) BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) BPD infants without typical chest imaging findings
Overall Study STARTED	78	178
Overall Study COMPLETED	78	178
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis of BPD in Premature Infants With Typical Imaging Changes

Baseline characteristics by cohort

Measure	Typical Imaging Finding (+) n=78 Participants Infants with typical imaging findings	Typical Imaging Finding (-) n=178 Participants Infants without typical imaging findings	Total n=256 Participants Total of all reporting groups
Age, Continuous	29.4 months n=5 Participants	30.6 months n=7 Participants	30.3 months n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	70 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	108 Participants n=7 Participants	148 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	78 Participants n=5 Participants	178 Participants n=7 Participants	256 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: between 28 days after birth and 2 years of age

Population: number of each group after PSM

the number of death/total number（%）

Outcome measures

Measure	Typical Imaging Findings (+) n=58 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=58 Participants BPD infants without typical chest imaging findings
Mortality	17 Participants	7 Participants

PRIMARY outcome

Timeframe: 36 wk PMA(infants with GA>32w) or>28 d but <56 d(infants with GA>32w) or discharge to home, whichever comes first

Population: After psm,each group has 58 infants

Mild BPD: Breathing room air Moderate BPD: Need* for < 30% oxygen Severe BPD: Need* for ≥ 30% oxygen and/or positive pressure

Outcome measures

Measure	Typical Imaging Findings (+) n=58 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=58 Participants BPD infants without typical chest imaging findings
Number of Participants According to the Severity of BPD severe BPD	19 Participants	7 Participants
Number of Participants According to the Severity of BPD mild-moderate BPD	39 Participants	51 Participants

PRIMARY outcome

Timeframe: at discharge, an average of 2 months

Population: each group has 58 infants after PSM

need of home oxygen therapy (HOT) at discharge

Outcome measures

Measure	Typical Imaging Findings (+) n=58 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=58 Participants BPD infants without typical chest imaging findings
Number of Participants Who Need HOT at Discharge	43 Participants	27 Participants

SECONDARY outcome

Timeframe: at discharge, an average of 2 months

Population: each group has 58 infants after PSM

days between admission and first discharge

Outcome measures

Measure	Typical Imaging Findings (+) n=58 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=58 Participants BPD infants without typical chest imaging findings
Duration of Hospital Stay	59 days Interval 33.8 to 68.2	56.5 days Interval 45.2 to 65.0

SECONDARY outcome

Timeframe: 2 Years of Age

Population: each group has 58 infants after PSM; 17 and 7 infants died in each group before they reached 2 years old.

the measure of infant's length and weight: Underweight/Stunting Stunting was defined as >2 standard deviations (SD) below the mean length for age, and underweight was defined as >2 SD below the mean weight for age. Weight and length were calculated with Chinese growth reference standards

Outcome measures

Measure	Typical Imaging Findings (+) n=41 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=51 Participants BPD infants without typical chest imaging findings
Routine Physical Assessment Underweight	3 Participants	4 Participants
Routine Physical Assessment Stunting	4 Participants	7 Participants
Routine Physical Assessment children without underweight and stunting	34 Participants	40 Participants

SECONDARY outcome

Timeframe: at discharge, an average of 46-56 days

Population: each group has 58 infants after PSM

days during which the infants were given oxygen supplement

Outcome measures

Measure	Typical Imaging Findings (+) n=58 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=58 Participants BPD infants without typical chest imaging findings
Days of Oxygen Supplement	56 days Interval 32.7 to 68.2	46 days Interval 38.0 to 56.2

SECONDARY outcome

Timeframe: between discharge and follow-up, an average of 22 months

Population: each group has 58 infants after PSM; 17 and 7 infants died in each group during the follow-up

Wheezing disorders were defined as a physician diagnosis of wheezing exposure treated with anti-asthma drugs (bronchodilators and corticosteroids)

Outcome measures

Measure	Typical Imaging Findings (+) n=41 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=51 Participants BPD infants without typical chest imaging findings
Wheezing Disorders	5 Participants	3 Participants

SECONDARY outcome

Timeframe: between discharge and follow-up until 2 years of age, an average of 22 months

Population: each group has 58 infants after PSM; 17 infants and 7 infants died in each group during follow-up

clinical visits and rehospitalizations for a respiratory reason

Outcome measures

Measure	Typical Imaging Findings (+) n=41 Participants BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=51 Participants BPD infants without typical chest imaging findings
Clinical Visits and Rehospitalizations Clinical visits <5 times	20 Participants	33 Participants
Clinical Visits and Rehospitalizations Clinical visits 5-10 times	11 Participants	10 Participants
Clinical Visits and Rehospitalizations Clinical visits >10 times	10 Participants	8 Participants

Adverse Events

Typical Imaging Findings (+)

Serious events: 19 serious events

Other events: 4 other events

Deaths: 17 deaths

Typical Imaging Findings (-)

Serious events: 7 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Measure	Typical Imaging Findings (+) n=78 participants at risk；n=58 participants at risk BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=178 participants at risk；n=58 participants at risk BPD infants without typical chest imaging findings
General disorders severe bpd	32.8% 19/58 • Number of events 19 • Admission date, 2 years	12.1% 7/58 • Number of events 7 • Admission date, 2 years

Other adverse events

Measure	Typical Imaging Findings (+) n=78 participants at risk；n=58 participants at risk BPD infants with typical chest imaging findings( including fibrotic opacities and cysts on CXR or CT scans during the entire hospital stay.)	Typical Imaging Findings (-) n=178 participants at risk；n=58 participants at risk BPD infants without typical chest imaging findings
General disorders leucomalacia	5.1% 4/78 • Number of events 4 • Admission date, 2 years	3.4% 6/178 • Number of events 6 • Admission date, 2 years

Additional Information

no sponsor, PI: Yuan Shi

CHCMU

Phone: 13508320283

Email: shiyuan@hospital.cqmu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place